Programme

The training course on visual inspection which takes place the day before the Particles Conference gives you an understanding of the fundamentals of visual inspection of injectable products, applicable to manual and automated inspection. You will also learn how to implement an automated system on the basis of the manual inspection. The course also includes an AQL training, that is you will learn how to use AQL tables to set defect limits and how to evaluate batch inspection data.

Presentation and discussion of the ECA Best Practice Paper on Visual Inspection
The best practice paper has been originally developed by the advisory board of the ECA Visual Inspection Group. Much rather than a strict requirement document, this paper is intended to be a reference for controversial issues. The first version of this paper has been published in September 2014 in Copenhagen. It has gained a broad acceptance in the industry afterwards. The current version as well as planned updates will be explained and discussed in Vienna.FDA’s current thinking on particles and testing of parenterals

A summary of recent recall data due to visible particulates

The FDA’s take on AQL testing

Training and qualification of visual inspection staff

Automated inspection validation

A lifecycle approach to visible particle inspection and control

Particles in Parenterals: Methods for the root cause analysis

Isolation of single particles

Analysis of particles using FTIR, REM-EDX, and ICP-MS

Usage of witness-wafers

Intrinsic particles and their origin

What can we learn from aerospace research.

Examples

Qualification in manual visual inspection in a multi-product environment

Defects and defect categorisation in the manual visual inspection of vials and ampoules

Composition and qualification of test sets

Initial qualification of human inspectors

Bracketing of products in the context of the qualification of human inspectors

Requalification and continuous evaluation of the inspectors performance

Maintaining the qualified state of the test sets

Validation of an Automated Inspection System - Alternative Ways for the 5000 Test

General requirements: Requirements of the Pharmacopeia, Defect categorisation. Test kits for training, qualification and routine

Manual Inspection: Training and qualification of manual operators, Standardisation of working conditions, AQL in the manual inspection

Automated inspection: Setup of the vision system, Qualification of the machine in 3 steps, Detection verification using probabilistic models (i.e. Knapp-Test / Particle-Qualification-Kit), Detection verification using fixed detection rates (i.e. Standard-Defect-Kit), Man-machine-comparison during production run (test of 5000), Alternatives for the test of 5000

Others: System-Suitability-Test, requalification and revalidation

Visual Inspection and Health Authority Expectations & Observations

Observation at the AIM qualification

Comments to the 5000 test

Dealing with particles & complaints

Particle testing and the correlation with trending and Batch release

Why do we Monitor (What is it all about)

Data and Measurement

The AQL trap

Improvement Process Map

Investigation and Routine Analysis,

Release Process. “To AQL or not to AQL that is the Question”

Product Release: “Falling off a log”

Particles in Biotech Parenteral Products

Particles are a major challenge in the development, manufacture and analysis of Parenteral Products

The Pharmacopeias and guidances aim towards minimizing visible particulates, yet, the requirements not easy to translate into everyday practice

Particles can come from different sources and USP has suggested a categorization with particles being extrinsic, intrinsic or inherent, yet, clinical relevance and safety of these would not be necessarily different and identification is often not unambiguous